Medical Device User Fee Reauthorization & FDA Update Roadmap to a Successful 510(K) Submission For Your Medical Device August 22, 2012

AGENDA How Did We Got Here? Device User Fee Renewal FDA Regulatory Environment

510(k) review times have risen 46% since 2007 as approval volume has trended down

User Fee Reauthorization: 510(k) Performance Improvements Decision made within 90 (FDA) Days – 2013: 91% of submissions – 2014: 94% – 2015: 95% Avg total time to decision in calendar days – 2013 submissions: 135 days – 2015 submissions: 130 days – 2017 submissions: 124 days

User Fee Reauthorization: Regulatory Process Reforms Communications/Interaction Improvements – Pre-Submission meetings – Midway review feedback (60 day from submission for 510(k)s) – Documentation/Review of Agency decisions Submitter may request supervisory review within 30 days of decision

User Fee Reauthorization: Regulatory Process Reforms IDE Standard – Agency cannot disapprove IDEs because the investigation does not: (1)support a substantial equivalence or de novo determination or approval (2)may not meet any requirement (including data requirement) (3)additional or different investigations may be necessary to support clearance or approval of the device.

User Fee Reauthorization: Regulatory Process Reforms 510(k) Modifications: – Agency forced to withdraw draft guidance – Require Agency to submit report to Congress addressing the key substantive, and controversial, provisions of the guidance – Precludes Agency from issuing regulation or guidance before 1 year after submission of the report

User Fee Reauthorization: Regulatory Process Reforms De Novo Process Modification: – Eliminates NSE requirement – Allows de novo submitters to submit request for classification and draft special controls – Establishes 120 day timeline for FDA to classify the device – FDA can refuse de novo request where: A predicate exists Device is not low or moderate risk General controls or special controls cannot mitigate risks

User Fee Reauthorization: Regulatory Process Reforms Clarification of Least Burdensome standard Reauthorization of Third-Party Review Device Reclassification Procedures Humanitarian Device Exemptions Unique Device Identifier (UDI) -- for devices that are implantable, life-saving and life- sustaining Inclusion of devices in FDA Sentinel program

FDA Regulatory Environment: Medical Device Tax Begins in 2013 $30 billion tax Potential 43,000 jobs lost Update on repeal efforts

Healthcare Reform Implementation Supreme Court ruling offers some finality Next major steps: – Accountable Care Organizations – Essential benefits package – Insurance exchanges – Medicaid expansion – Independent payment advisory board Impact on VC & start-ups